Job Description

RadioMedix Inc., a Biotechnology Company located at 9701 Richmond Ave Houston, Texas 77042, is seeking an entry-level Quality Assurance Investigator to work in radiopharmaceutical manufacturing.  The successful candidate will play a key role in conducting Quality Assurance investigations of all drug products on-site. The focus of the position will be to focus on high-priority projects at RadioMedix that will be integral to upcoming clinical trials. This is a newly created position with potential for significant growth.

We’re a growing company and we continue to add talent from a variety of fields. RadioMedix seeks to hire highly motivated and forward-thinking professionals interested in nuclear medicine research and development and influencing change within the Nuclear Medicine landscape.

Roles/Deliverables

• The Quality Assurance Investigator is responsible for performing investigations and driving each event to a conclusion by working with other stakeholders
• The QA Investigator also ensures the investigation outcome, root cause analysis, and resulting solutions (CAPAs) and deviations are completed in a timely, effective, and compliant manner
• Conducts organized investigations with a well-defined scope, strategy, and timeline documenting the status and progress of the investigation and CAPAs and deviations
• Authors reports that documents the investigation of issues including definition, scope, product impact, root cause, and corrective actions to prevent the recurrence of the issue
• Seeks and demonstrates the skills and technical expertise of internal and external resources to improve the speed and thoroughness of investigations
• Collaborates with all appropriate stakeholders to determine root causes of all quality events
• Communicates strategy so all collaborators have appropriate information
• Investigation strategy, including a clear and practical problem statement
• Investigation action plan and timing
• CAPA action plan and effectiveness checks
• Utilizes the appropriate and approved investigation tools necessary to drive the team to root cause for CAPAs and Deviations
• Responsible for supporting Quality Operations tasks including but not limited to:
  • Batch Record review and approval
  • Quality on the Floor
  • Management of equipment calibration schedule
• Prioritizes work to aid in timely decisions and completion of investigations
• Escalates issues as appropriate
• Works within and across functions to ensure connectivity of investigations between functional areas and sites
• Completes other duties as assigned
• Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct
• Completes all required training on time
• Reports potential issues of non-compliance
• Ensures compliance with RadioMedix site Standard Operating Procedures, regulatory requirements, and industry best practice (cGMPs)

Maintains a safe work environment and performs work in accordance with EH&S practices

Work Conditions
The work environment consists of manufacturing, laboratory, and office spaces. The position will sometimes require more than forty hours of work per week.  The work period is typically between 8:30 AM to 5 PM.
Individuals in this position will be expected to support both the corporate site and manufacturing site(if needed).

Individuals in this position will be exposed to ionizing radiation; however, radiation safety training will be provided, and radiation monitoring is required and ongoing at the facilities.  Any exposure will be within Federal and State limits. Individuals in this position are required to be able to function and maneuver within the work environment without placing self, product or others at risk.

Benefits :
Health, Dental & Vision Insurance (effective 1st day of the following month after the start date)

Job Tags

Full time,

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